Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Prevention Education in Caries Formation in Pediatric Patients With Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281746
Recruitment Status : Terminated (Slow accrual)
First Posted : September 13, 2017
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
This randomized pilot clinical trial studies how well preventive education works in decreasing caries formation in pediatric patients with leukemia. Prevention education may have an effect on factors important in causing cavities in pediatric patients with leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Procedure: Dental Procedure Other: Educational Intervention (prevention education) Other: Interview Other: Survey Administration Other: Educational Intervention (one-on one education) Not Applicable

Detailed Description:
Patients treated for leukemia at Virginia Commonwealth University Medical Center in the department of Pediatric Hematology and Oncology are currently receiving oral hygiene instruction at diagnosis. In this study, patients will be randomized into two groups at diagnosis: one receiving current prevention education and the other group receiving one-on‐one prevention education and counseling with the physician and pediatric dental resident. Physician and pediatric dental resident will use motivational interviewing informed techniques during counseling. A caries risk assessment will be performed for each patient at diagnosis. Caries incidence, plaque scores, mutans streptococci levels, salivary flow rate, and salivary pH will be assessed at week one (diagnosis), week 16 or start of interim maintenance therapy whichever comes second, week 32 or beginning of maintenance therapy whichever is later for all patients enrolled in the study. Data will be collected through a clinical intraoral examination and salivary sample. Data collected will be used to assess the effect of increased prevention education on factors of importance in caries formation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Prevention Education on Factors of Importance in Caries Formation in Pediatric Patients With Leukemia
Actual Study Start Date : May 19, 2017
Actual Primary Completion Date : March 2, 2018
Actual Study Completion Date : March 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Active Comparator: Group I (standard prevention education)
Patients undergo dental examination at baseline and then receive standard prevention education at diagnosis discussing the effects of prolonged neutropenia on oral hygiene, importance of a regular oral hygiene regimen, and the long term clinical outcomes of oncologic patients. Patients also receive fliers with pictograms describing proper brushing, use of mouth wash, and common oral complications during therapy, as well as a bottle and prescription for chlorhexidine gluconate 0.12% rinse.
Procedure: Dental Procedure
Undergo dental examination

Other: Educational Intervention (prevention education)
Receive prevention education
Other Names:
  • Education for Intervention
  • Intervention by Education

Other: Interview
Ancillary studies

Other: Survey Administration
Ancillary studies

Experimental: Group II (standard and one-on-one education, consultation)
Patients undergo dental examination and receive standard prevention education as in Group I. Patients also receive one-on-one prevention education and counseling with the physician and pediatric dental resident.
Procedure: Dental Procedure
Undergo dental examination

Other: Educational Intervention (prevention education)
Receive prevention education
Other Names:
  • Education for Intervention
  • Intervention by Education

Other: Interview
Ancillary studies

Other: Survey Administration
Ancillary studies

Other: Educational Intervention (one-on one education)
Receive one-on-one education
Other Names:
  • Education for Intervention
  • Educational Intervention
  • Intervention by Education
  • Intervention through Education




Primary Outcome Measures :
  1. Change in caries assessed by CAMBRA risk assessment tool [ Time Frame: Baseline up to 32 weeks ]
  2. Change in salivary flow rate [ Time Frame: Baseline up to 32 weeks ]
    Change in salivary flow rate will be measured utilizing pre-weighed cotton rolls. Patients will saturate as many cotton rolls as possible in one minute by chewing. Dose cups and cotton rolls will be weighed prior to and after data collection. The change in weight in grams will be converted to mL of saliva collected.

  3. Change in salivary pH [ Time Frame: Baseline up to 32 weeks ]
    Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.

  4. Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth [ Time Frame: Baseline up to 32 weeks ]
    Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.

  5. Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS) [ Time Frame: Baseline up to 32 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients who have been recently diagnosed with leukemia
  • Patients will also predictably be in primary or mixed dentition
  • Patients of Virginia Commonwealth University Medical Center Pediatric Hematology Oncology Clinic

Exclusion Criteria:

  • Full permanent dentition
  • Primary language is not English
  • Children in the custody of the state with no parent or legal guardian present to sign consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281746


Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Helou A Marieka, MD, MPH Virginia Commonwealth University
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03281746    
Other Study ID Numbers: MCC-16-13019
NCI-2017-01354 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Neoplasms by Histologic Type
Neoplasms